Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility.
Because of this production-line issue at the firm''s plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.

FDA DeterminedCause 2

PRODUCTION CONTROLS: Equipment Maintenance

Action

Beginning on September 15, 2006, a product notification letter was sent via facsimile or communicated via telephone with each of the customer accounts. Beginning on September 19, 2006, an AMO Japan sales representative visited each of the customer accounts obtaining COMPLETE Amino Moist Multi-Purpose Solution subject to recall.
Letters dated November 21, 2006 were sent from AMO, Santa Ana, California beginning Novemer 27, 2006.